HXB · Probe
Orthopedic · 21 CFR 888.4540 · Class 1
Overview
| Product Code | HXB |
|---|---|
| Device Name | Probe |
| Regulation | 21 CFR 888.4540 |
| Device Class | Class 1 |
| Review Panel | Orthopedic |
Identification
An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery. This generic type of device includes the cerclage applier, awl, bender, drill brace, broach, burr, corkscrew, countersink, pin crimper, wire cutter, prosthesis driver, extractor, file, fork, needle holder, impactor, bending or contouring instrument, compression instrument, passer, socket positioner, probe, femoral neck punch, socket pusher, reamer, rongeur, scissors, screwdriver, bone skid, staple driver, bone screw starter, surgical stripper, tamp, bone tap, trephine, wire twister, and wrench.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.
Cleared Devices (15)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K960539 | DIAO HAND SURGERY SET | Kinetikos Medical, Inc. | Jul 23, 1996 | SESE |
| K943472 | COHORT AVB RETRACTOR SYSTEM | Cohort Medical Products Group, Inc. | Oct 20, 1994 | SESE |
| K912843 | FLEXMEDICS RETRACT ORTH PROBE, PETTINE BONE PROBE | Flexmedics | Sep 24, 1991 | SESE |
| K890227 | SURGICAL PROBE | Kinetic Medical Products | Jan 27, 1989 | SESE |
| K873652 | HOOK PROBE #TM-1376 | Arthropedics, Inc. | Nov 2, 1987 | SESE |
| K873651 | BLUNT MEASURING PROBE W/2MM GRADATIONS #TM-1375 | Arthropedics, Inc. | Nov 2, 1987 | SESE |
| K863149 | BOWEN PROBE | Bowen & Company, Inc. | Sep 5, 1986 | SESE |
| K841971 | 2.5MM & 4MM PROBE K841969-LABELING | Stainless Mfg., Inc. | Jun 19, 1984 | SESE |
| K840558 | SHUTT PRECISION PROBES | Concept, Inc. | Apr 25, 1984 | SESE |
| K810294 | LINE CADDY | Instranetics, Inc. | Feb 26, 1981 | SESE |
| K802951 | I.M PROBES | Hogan & Hartson | Dec 17, 1980 | SESE |
| K802479 | SURGICAL KNIVES & PROBES | Eder Instrument Co, Inc. | Oct 31, 1980 | SESE |
| K800729 | PROBE | Stainless Mfg., Inc. | Apr 8, 1980 | SESE |
| K800444 | GOLDEN RETRIEVERS OR SILVER RETRIEVERS | Instrument Makar, Inc. | Mar 5, 1980 | SESE |
| K800274 | ACUFEX PROBES | Acufex Microsurgical, Inc. | Feb 19, 1980 | SESE |
Top Applicants
- Stainless Mfg., Inc. — 2 clearances
- Arthropedics, Inc. — 2 clearances
- Kinetikos Medical, Inc. — 1 clearance
- Kinetic Medical Products — 1 clearance
- Instrument Makar, Inc. — 1 clearance
